Trials / Completed
CompletedNCT01022255
Autologous Vaccine for Follicular Lymphoma
Phase I Study of an Autologous Recombinant Idiotypic Vaccine Manufactured by magnICON® Technology for the Treatment of Patients With Relapsed or Transformed Follicular Lymphoma
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 28 (actual)
- Sponsor
- Icon Genetics GmbH · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This phase I study will evaluate the safety and tolerability of an autologous idiotype vaccine manufactured by magnICON technology for patients with relapsed follicular lymphoma who are in complete or partial remission following non-antiCD20 containing salvage therapy. Data in terms of idiotype-specific immune responses will also be obtained.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Autologous FL vaccine | 1.0 mg of vaccine subcutaneously (s.c.) on Day 1, and followed by 125 µg GM-CSF s.c. at Day 1 -4, monthly until 8th vaccination, bimonthly until 12th vaccination (month 16) |
Timeline
- Start date
- 2010-01-01
- Primary completion
- 2013-10-01
- Completion
- 2013-10-01
- First posted
- 2009-12-01
- Last updated
- 2014-01-30
Locations
3 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01022255. Inclusion in this directory is not an endorsement.